FUJIFILM Healthcare Americas Corporation recalls ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast…
Devices had an unapproved slabbing software function enabled for use.
Read the official notice →- Date
- 2025-08-06
- Country
- United States
- Brand
- FUJIFILM Healthcare Americas
- Product
- ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Canada, Chile,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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